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Innovus Pharma’s Partner Bio Task Receives Approval for Zestra® as a Cosmetic from the National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia for Arousal and Desire

2017年11月30日 AM03:33
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SAN DIEGO

Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases, announced today that its partner Bio Task SDN BHD (“Bio Task”) received approval to commercialize Innovus Pharma’s product Zestra® as a Cosmetic from the National Pharmaceutical Regulatory Agency (“NPRA”), Ministry of Health, Malaysia for arousal and desire.

“We are pleased that our partner, Bio Task recently received approval for Zestra® as a cosmetic in Malaysia,” said Innovus Pharma CEO, Dr. Bassam Damaj. “We look forward to working with Bio Task on the launch of the product and other products that they have licensed from us in that country.”

Innovus Pharma signed in November 2015 an exclusive license and distribution agreement with Bio Task, a company based in Malaysia, for the commercialization of Zestra® for arousal and desire in women and for Zestra Glide® as a lubricant, Sensum+® to increase penile sensitivity, EjectDelay® for treatment of Premature Ejaculation and for Vesele® to increase sexual and cognitive functions in men and women.

Besides, Bio Task, Zestra® is currently exclusively partnered with Orimed Pharma, the OTC subsidiary of Jamp Pharma in Canada, Densmore in France and Belgium, DanaLife ApS in select European markets, Sothema Laboratories for the Middle East and North Africa, Elis Pharmaceuticals in Turkey and certain select markets, and Li USA, Co. for South Korea, and non-exclusively to PT Resources in Hong Kong and certain select Asian markets.

Zestra® is currently approved to be commercialized in 37 countries in the world namely, in Canada, the 28 countries of the European Union, Australia, New Zealand, India, Hong Kong, the United Arab Emirates (“UAE”), South Korea, Morocco and Malaysia. Innovus Pharma currently generates revenues from the following markets for Zestra®: Canada, Australia, Morocco, certain European countries, South Korea and Hong Kong in addition to the United States as its biggest market.

About Zestra® and FSI/AD

Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. To the Company’s knowledge, Zestra® is the first NHP product to receive approval for the indication of FSI/AD in Canada. To date, no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it to be equal or larger than the market for erectile dysfunction in males, and possibly larger.

Approximately 43% of women in the United States age 18 to 59, or ~50 million, experience some form of Female Sexual Dysfunction (“FSD”) according to a published study. (Laumann, E.O. et al. Sexual Dysfunction in the United States: Prevalence and Predictors. JAMA, Feb. 10, 1999. vol. 281, No. 6.537-542) and (http://www.indexmundi.com/south_korea/demographics_profile.html). The FSD market in the United States is estimated to be more than $1 billion per year. For more information on Zestra®, please visit www.zestra.com.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our on-line channels, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.

For more information, go to www.innovuspharma.com, www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com; www.myandroferti.com; www.fluticare.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.prostagorx.com; and www.allervarx.com

Innovus Pharma’s Forward-Looking Safe Harbor

Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, to successfully commercialize Zestra® and other products in Malaysia and internationally and to achieve its other development, commercialization, financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s most recent filing on Form S-1, annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC’s website or without charge from the Company.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171129006051/en/

CONTACT

Emerging Markets LLC
James S. Painter
407 340 0226
jamespainter@emergingmarketsllc.com

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